DepressionNCPNCT05139862
Neurocardiac Predictors of Treatment Response to RTMS in Depression
A study testing Repetitive Transcranial Magnetic Stimulation in people with Depression and Treatment Resistant Depression, run by University of British Columbia at 1 site in Canada.
Trial summary
Heartbeat is controlled by the brain and is regular but flexible to change in response to environmental and internal stimuli. This feature is known as heart rate variability (HRV). Major depressive disorder (MDD) has been associated with diminished HRV and this is a reflection of abnormal brain function caused by MDD. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Treatment Resistant Depression
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be included if they:
- are female or male;
- are outpatients;
- are voluntary and competent to consent to treatment;
- have a DSM 5 diagnosis of MDD, single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 6.0;
- are between the ages of 18 and 65 years;
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- have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode OR have been unable to tolerate at least two separate trials of antidepressants at less than the minimum adequate dose and/or duration (ATHF 1 or 2);
- A score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item);
- Have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
- Able to adhere to the treatment schedule;
- pass the TMS and MRI adult safety screening questionnaires.
Who cannot join
- Patients are excluded if they:
- have a history of substance use within the last 3 months;
- have a concomitant major unstable medical illness;
- have active suicidal intent;
- are pregnant;
- have a lifetime (MINI) diagnosis of any psychotic or bipolar disorder;
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- have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDD;
- have ever failed a course of ECT;
- have previously received rTMS;
- have any significant neurological disorder, any history of seizure (except those therapeutically induced by ECT), significant head trauma with loss of consciousness for > 5 min;
- have any intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study;
- have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
- are currently taking lorazepam greater than 2 mg daily (or equivalent) or any dose of an anticonvulsant, due to the potential to limit rTMS efficacy;
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);
- have failed more than three adequate trials (ATHF > 3) of medication in the current episode.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry
Vancouver, British Columbia, V6T 2A1
Quincy Beck, B.Sc., 604-822-7308, quincy.beck@ubc.ca
Fidel Vila-Rodriguez, M.D., Ph.D.
About this study
Official title: Neuro-cardiac Predictors of Treatment Response to RTMS in Depression: a Mechanistic Study Using Interleaved TMS-fMRI
Heartbeat is controlled by the brain and is regular but flexible to change in response to environmental and internal stimuli. This feature is known as heart rate variability (HRV). Major depressive disorder (MDD) has been associated with diminished HRV and this is a reflection of abnormal brain function caused by MDD. Repetitive transcranial magnetic stimulation (rTMS) is a treatment that stimulates specific areas of the brain. The goal of this study is to test the hypothesis that rTMS induces changes in connectivity between the area of the brain stimulated with rTMS and deeper areas in the brain associated to heart rate regulation. 110 patients with TRD will be recruited and will undergo a concurrent TMS-fMRI session before receiving a course of iTBS to the L-DLPFC for 30 sessions at 120% rMT.
- Conditions
- Depression, Treatment Resistant Depression
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, rTMS, Neurostimulation, Heart Rate Variability, fMRI
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called rTMS
This study utilizes intermittent theta burst stimulation (iTBS) to the left DLPFC.
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS | Experimental | Active intermittent theta-burst stimulation (iTBS) rTMS session on the left dorsolateral prefrontal cortex (L-DLPFC) Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Depressive Symptoms using HDRS-17 Scale at Week 10
The 17-item Hamilton Depression Rating Scale (HRSD-17) will be used as the primary outcome measure as well as the tool to establish severity cut off for eligibility (Hamilton, 1960). The scoring ranges from 0-52, with higher scores indicating more severe depression symptoms.
Measured: Baseline and Week 10
Secondary outcomes (2)
Change from Baseline in Anxiety Symptoms using HAM-A Scale at Week 10
The 14-item Hamilton Anxiety Rating Scale (HAM-A) will be used as a secondary outcome measure in this study. The scoring of this assessment ranges from 0-56, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline and Week 10
Change from Baseline in Depressive Symptoms using QIDS-16 Scale at Week 10
The self-rated 16-item Quick Inventory of Depressive Symptoms (QIDS-16) will be used as a secondary outcome measure in this study. The scoring of this assessment ranges from 0-27, with higher scores indicating more severe depression symptoms.
Measured: Baseline and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 May 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- For MDD patients, the study will consist of six weeks of rTMS treatment using intermittent theta burst stimulation (iTBS) rTMS to the left DLPFC. Treatment will be administered daily, 5 days per week (i.e., 30 treatments).
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA, University of British Columbia
- Investigators
- Fidel Vila-Rodriguez, M.D., Ph.D., Principal investigator, Department of Psychiatry, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139862
- Sponsor's protocol ID
- H19-00648
- Acronym
- NCP
- Status last verified
- Dec 2024
- First submitted
- 17 Nov 2021
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-cardiac Predictors of Treatment Response to RTMS in Depression: a Mechanistic Study Using Interleaved TMS-fMRI
- ClinicalTrials.gov ID
- NCT05139862
- Acronym / sponsor ID
- NCP / H19-00648
- Conditions
- Depression, Treatment Resistant Depression
- Keywords
- Repetitive Transcranial Magnetic Stimulation, rTMS, Neurostimulation, Heart Rate Variability, fMRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heartbeat is controlled by the brain and is regular but flexible to change in response to environmental and internal stimuli. This feature is known as heart rate variability (HRV). Major depressive disorder (MDD) has been associated with diminished HRV and this is a reflection of abnormal brain function caused by MDD. Repetitive transcranial magnetic stimulation (rTMS) is a treatment that stimulates specific areas of the brain. The goal of this study is to test the hypothesis that rTMS induces changes in connectivity between the area of the brain stimulated with rTMS and deeper areas in the brain associated to heart rate regulation. 110 patients with TRD will be recruited and will undergo a concurrent TMS-fMRI session before receiving a course of iTBS to the L-DLPFC for 30 sessions at 120% rMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For MDD patients, the study will consist of six weeks of rTMS treatment using intermittent theta burst stimulation (iTBS) rTMS to the left DLPFC. Treatment will be administered daily, 5 days per week (i.e., 30 treatments).
| Arm | Type | Receives |
|---|---|---|
| Active iTBS | Experimental | Device: Repetitive Transcranial Magnetic StimulationActive intermittent theta-burst stimulation (iTBS) rTMS session on the left dorsolateral prefrontal cortex (L-DLPFC) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- are female or male;
- are outpatients;
- are voluntary and competent to consent to treatment;
- have a DSM 5 diagnosis of MDD, single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 6.0;
- are between the ages of 18 and 65 years;
Key exclusion criteria (16 listed)
- have a history of substance use within the last 3 months;
- have a concomitant major unstable medical illness;
- have active suicidal intent;
- are pregnant;
- have a lifetime (MINI) diagnosis of any psychotic or bipolar disorder;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: rTMSThis study utilizes intermittent theta burst stimulation (iTBS) to the left DLPFC. | Device | Active iTBS |
Primary outcome
Change from Baseline in Depressive Symptoms using HDRS-17 Scale at Week 10
Time frame: Baseline and Week 10
The 17-item Hamilton Depression Rating Scale (HRSD-17) will be used as the primary outcome measure as well as the tool to establish severity cut off for eligibility (Hamilton, 1960). The scoring ranges from 0-52, with higher scores indicating more severe depression symptoms.
2 secondary outcomes
Change from Baseline in Anxiety Symptoms using HAM-A Scale at Week 10
Time frame: Baseline and Week 10
Change from Baseline in Depressive Symptoms using QIDS-16 Scale at Week 10
Time frame: Baseline and Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fidel Vila-Rodriguez, M.D., Ph.D. principal investigator
Department of Psychiatry, UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Depression and Treatment Resistant Depression, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Layton (604-822-7308, ninet.lab@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Depressive Symptoms using HDRS-17 Scale at Week 10 (time frame: Baseline and Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.